Drug Delivery Management System

ABSTRACT

The present invention relates to assisting patients in the taking of medication, and to assisting third parties in accumulating information regarding patient medication intake. The invention may be embodied a system including a portable medication monitor used in association with an instrumented medication package to provide intake data acquisition and patient support functions. The system may further be connected to a computer or computer network allowing information distribution between the medication monitor and third parties, such as physicians or pharmacists.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/187,727, which is a divisional of U.S. Pat. No. 6,961,285, filed Sep.3, 2002, which is a continuation-in-part of U.S. Pat. No. 6,574,166,filed Jul. 9, 2001, which is a continuation-in-part of U.S. Pat. No.6,411,567, filed Jul. 7, 2000. The entire disclosures of U.S. patentapplication Ser. No. 11/187,727 and U.S. Pat. No. 6,961,285 areincorporated by reference herein as if set forth in their entireties.

FIELD OF THE INVENTION

The present invention pertains to the accumulation and dissemination ofinformation associated with the taking of medications, and moreparticularly to the acquisition, dissemination, and utilization ofinformation obtained through implementation of an instrumentedmedication package.

BACKGROUND OF THE INVENTION

The explosive developments in medical treatment relating to drugs havecreated a costly and high risk drug management environment. A 1995 studypublished in the “Archives of Internal Medicine” estimates that $76billion is spent each year in the U.S. on extra doctor visits andhospitalization because people do not take their medication properly. Inaddition, a 1999 study by the National Academy of Science, Institute ofMedicine, describes errors made in the hospitals which threatenpatient's health. The study estimated that 98,000 patients die each yearbecause of medical mistakes. Prescription drug errors are one of themajor areas where mistakes are made.

Unit-dose blister type packaging for prescription drugs is one of thefastest growing package formats and is projected to be at 40%penetration in the U.S. market by 2003. Blister packages are already thedominant prescription drug package format in Europe with 85%penetration. Some of the reasons behind this growing use of blisterpackaging are: (i) product integrity being maintained throughout out thedrug life cycle, (ii) better product protection to insure quality andefficacy of the drug, (iii) better tamper evidencing and childresistance, and (iv) improved patient compliance in that unit-doseblister packaging gives patents a clearly marked individual dosage.

The ability to obtain data regarding the usage of medications through ablister pack containing devices for monitoring the accessing ofindividual containments within the packaging is described in severalreferences, including Applicant's U.S. patent application Ser. No.09/611,582. These references teach monitoring the accessing ofindividual containments to determine whether and when a medication wastaken, in order to accumulate information regarding the medicationintake.

The taking of medications has become a central aspect of life.Individuals may take over the counter or prescription medications for awide range of ailments. The effectiveness of the medications may bedependent on a patient's punctuality of application or ingestion(hereinafter referred to generically as “medication intake”) of themedication at issue.

The punctuality with which a patient takes medication may affect everyentity in the health care chain. The patient taking the medication ontime increases the likelihood that the medication will be effective,thus reducing disadvantages associated with the medical condition forwhich the medication is being taken. These disadvantages may includework time lost due to the condition as well as patient discomfortassociated with the condition. The improved effectiveness associatedwith timely medication also benefits physicians, by reducing thelikelihood that the medication will be unsuccessful in resolving thecondition, thus reducing the likelihood that additional visits arerequired to resolve the condition. Increased effectiveness associatedwith timely medication may also reduce the total amount of medicationneeded to be taken by a patient, thus reducing the cost of resolving themedical condition, such that expenses to health care insurers arereduced.

In order to assess the compliance of a patient taking medicationaccording to an intake schedule, instrumented medication packages havebeen developed. These packages incorporate a method of identifying thedispensation of medication from the package. The inclusion of a clockallows the information to be correlated to time. Early efforts used someform of memory associated with the package to store dispensation timeinformation for later downloading, such as when the package was returnedto a pharmacy or other download-capable site. The necessity of returningthe package to a specific location had several drawbacks, including thelack of incentive for a patient to return the package unless anotherprescription was to be picked up. Additionally, the dispensationinformation would not be available to anyone in the chain of entitiesinvolved in the treatment of the patient (the chain may include, but isnot limited to, a doctor, pharmacist, insurer, medication manufacturer,the patient him or herself, other caregivers, or anyone else involved inthe treatment of the patient) until after the package had been returned,and any data downloaded.

Applicant's earlier patent application disclosed the use of a network ofreceivers for receiving information from instrumented medicationpackages. One embodiment included the use of receivers located inhospital rooms to allow in-hospital monitoring of medication intake.Another embodiment utilized receivers located at diverse locations,including pharmacies and patient residences, to provide broader coveragefor acquiring information from instrumented medication packages.Additional embodiments included capabilities for monitoring additionalconditions associated with the taking of medication, including theconditions of storage of the instrumented medication package itself.

SUMMARY OF THE INVENTION

The present invention is a system and process for assisting patientswith medication compliance. The system combines an instrumentedmedication package with a portable medication monitor to provide supportto the patient in taking medication as directed. The system and processmay additionally be communicably connected to a third party computer orcomputer network to allow third parties to access information on themedication monitor or to provide information to the patient via themedication monitor. Additionally, the medication monitor, when connectedto a third party computer or computer network may be used to collectdata regarding medication compliance for use in determining the efficacyof medications being taken by the patient.

In one form, the present invention may be embodied in a medicationmonitoring system which includes an instrumented medication package. Theinstrumented medication may have a plurality of medication containments,each medication containments having an closure incorporating a severableconnector. The instrumented medication package may also include aninstrumented medication package receiver and an instrumented medicationpackage transmitter. The instrumented medication package receiver may beused for receiving trigger signals, and the instrumented medicationpackage transmitter may be used for transmitting information identifyingthe condition of the severable connectors. The system may also include amedication monitor. The medication monitor may have a medication monitortransmitter and a medication monitor receiver. The medication monitortransmitter may be used for transmitting a trigger signal, while themedication monitor receiver may be used for receiving informationtransmitted by an instrumented medication package transmitter.

In another form, the present invention may be embodied in aninstrumented medication package having a plurality of medicationcontainments. The medication containments each may have a closure havinga severable connector. The instrumented medication package may furtherhave an instrumented medication package transponder. The instrumentedmedication package transponder may be used for receiving triggersignals, and transmitting a response signal in response to the triggersignals. The instrumented medication transponder may further includepassive radio frequency identification circuitry. The passive radiofrequency identification circuitry may comprise circuitry which modifiesa response signal generated by the passive radio frequencyidentification circuitry, said response signal utilizing the energy ofthe trigger signal.

In a still further form, the present invention may be embodied in aportable medication monitor having a general purpose computingcircuitry, and an instrumented medication package transceiver. Theinstrumented medication package transceiver may include a transmitterand a receiver for transmitting to and receiving signals from aninstrumented medication package. The portable medication monitor mayfurther have a network connection for communicably connecting theportable medication monitor to at least one remote computer. Theportable medication monitor may also include software for monitoringinstrumented medication packages which may be associated with theportable medication monitor.

In a still further form, the present invention may be embodied in amethod for monitoring medication intake. The method may includeproviding an instrumented medication package and a medication monitor. Atrigger signal may be emitted from the medication monitor and receivedby the instrumented medication package. When the trigger signal isreceived, the instrumented medication package may transmit informationidentifying the condition of severable connectors. The transmittedinformation may be received at the portable medication monitor, whichmay then forward the information to a remote computer via a networkconnection.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an instrumented medication package associated with amedication monitor.

FIG. 2 illustrates an instrumented medication package associated with amedication monitor implemented within a health care network according tothe present invention.

FIG. 3 shows a process flowchart illustrating a process of using amedication monitor in association with an instrumented medicationpackage according to the present invention.

FIG. 4 shows a hybrid passive and active circuitry instrumentedmedication package associated with monitoring capabilities according tothe present invention.

FIG. 5 shows a hybrid passive and active circuitry instrumentedmedication package implemented in a pharmacy environment.

FIG. 6 shows a process flowchart illustrating a process of using ahybrid passive and active instrumented medication package according tothe present invention.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1, wherein like numbers represent like elements, there is shownan illustration of the components of a medication monitoring system 100according to the present invention. The system may have an instrumentedmedication package 102 and a medication monitor 104 associatedtherewith. The instrumented medication package 102 includes atransmitter 106 capable of transferring information associated with theinstrumented medication package 102 to the medication monitor 104. Themedication monitor 104 includes a receiver 108 for receiving informationfrom the instrumented medication package 102.

The medication monitor 104 is preferably portable, such that themedication monitor 104 may accompany a patient (not shown) as thepatient travels. The medication monitor 104 may include a processor 110which provides functionality for the medication monitor 104, such as inconjunction with operating instructions 112 or a computer program forcommunicating with the instrumented medication package 102 and handlingdata received from the instrumented medication package 102. Themedication monitor 104 may also be provided with a display 114 such thata patient may receive information or reminders regarding medication tobe taken. The display 114 may be aural tactile, or visual, or acombination thereof, such that reminders can be provided to a patient,such as a reminder that a dose of medication is due to be taken. Themedication monitor may also include memory 116 to allow the medicationmonitor 104 to be used as a data accumulator, such that informationretrieved from an instrumented medication package 102 may be removedfrom the instrumented medication package 102 once provided to themedication monitor 104, allowing reduced requirements for data storageintegral to the instrumented medication package 102.

The medication monitor 104 may also be provided with functionalityallowing information associated with the instrumented medication package102 to be displayed for the patient taking the medication. The use ofseverable conductors 118 in association with medication containments 120allows the detection of when a patient accesses medication (not shown).For example, a patient unsure of whether they took required medicationon time would be able to review the times at which medicationcontainments 120 were accessed, and compare this information with anintake schedule identifying when a dose was supposed to have been taken.Furthermore, the medication monitor 104 may be provided withfunctionality to allow a dosing schedule to entered into and displayedon the medication monitor 104, such that the patient would be easilyable to determine when a dose should have been taken, as well as whethera dose was accessed at the requisite time.

The medication monitor 104 may also be provided with a transmitter 122to allow the use of a transmission to trigger to be received by ainstrumented medication package receiver 124 an information transferfrom the instrumented medication package 102. The instrumentedmedication package 102 may utilize radio frequency identificationtechnology to provide data transmission from the instrumented medication102 package to the medication monitor 104. Radio frequencyidentification (RFID) technologies function as transponders, such thatreceipt of a trigger signal causes the RFID to respond with anidentification transmission. The identification transmission may includedata to be transmitted from the instrumented medication package 102 tothe medication monitor 104, such as times at which severable conductors118 were severed, or other information stored by the instrumentedmedication package 108.

Several methods for generating and types of trigger signals may beimplemented. The use of radio frequency signals allows a triggeringsignal unique to the instrumented medication package 102 to be utilized.The use of the unique trigger signal reduces the likelihood that thirdparties would be able to generate a trigger signal to receiveinformation from a instrumented medication package. The unique triggersignal may be associated with the actual medication package 102 itself,such that entry of an identifier into the medication monitor 104 mayallow the medication monitor 104 to be able to generate a trigger signalfor the instrumented medical package 102 for which an identifier hasbeen provided.

The medication monitor 104 may also be provided with functionality toallow the medication monitor 104 to receive information from more thanone instrumented medication package (102 b, 102 c) concurrently. As morethan one medication may be required to be taken by a patient during atime period, the ability of the medication monitor 104 to acquire dataand track multiple medications provides both an efficiency with regardsto the acquisition of information, as well as a convenience to thepatient, i.e., that a single medication monitor 104 may be used tosupport the taking of multiple medications.

In order to allow a single medication monitor 104 to receive informationfrom more than one instrumented medication package (102, 102 b, 102 c),a method of de-conflicting triggering and reception of information fromthe instrumented medication packaging may be implemented. Where activeRFID's are used, one solution may be to impose a communications protocolallowing information to be transmitted both from the instrumentedmedication package 102 to the medication monitor 104, and from themedication monitor 104 to the instrumented medication package 102. Theuse of two way communications also allows additional communicationssecurity to be enable between the medication monitor 104 and aninstrumented medication package 102, such that privacy issues regardingthe medication and its usage may be maintained. The imposition of aprotocol for such transmissions may also allow a single medicationmonitor 104 to be used with instrumented medication packages fromvarious suppliers, such that a patient would not be required to maintainmultiple medication monitors to allow the concurrent taking of multiplemedications when those medications are from more than one supplier.

Active RFIDs typically use a triggered response form of two waycommunication to allow the conservation of power within the RFID. Byonly transmitting information in response to a trigger signal, power canbe conserved by avoiding unnecessary transmissions. The use of triggercommon to multiple devices, however, may allow an instrumentedmedication package 102 to transmit a response whenever a trigger signalis received, whether or not the trigger signal was intended for theinstrumented medication package 102. Random triggering may also raisebattery life concerns, especially if unintended triggers are frequentlyreceived. Common trigger signals also make it more likely that thirdparties can successfully trigger information transmissions from aninstrumented medication package 102. Where health care is involved,privacy issues raise concerns regarding the ability of third parties toaccess patient care information. In the case of a medicatedinstrumentation package 102, information transmitted by a transmitterassociated with the package may provide information to third parties. Bylimiting the validity of a trigger signal to a specific signal, such asthe address identifying a specific instrumented medication package 102,the ability of third parties to trigger the transmission of informationfrom an instrumented medication package 102 may be sufficientlycurtailable to avoid privacy issues. The specific signal used may beimplemented by providing to the medication monitor 104 an identifyingnumber for the instrumented medication package 102, such as anidentifier containing both random and non-random portions. For example,a portion of an identifier may serve to identify the manufacturer of themedication, while another portion contains a random number associatedwith the particular instrumented medication package 102. By implementinga manufacturer identifier, individual manufacturers may be able toimplement the random number portion of the identifier without fear ofduplicating an identifier from a different manufacturer, such as wouldbe possible, albeit unlikely, if only a random number were used.

The processor 126 of the instrumented medication package 102 may monitortransmissions received by the instrumented medication package receiver104 in order to detect receipt of a correct trigger. Receipt of a signalby the receiver 124 may trigger the instrumented medication packageprocessor 126 to attempt to decode the signal to determine whether thesignal contains the correct information. If the signal contains thecorrect trigger information, the processor 126 may trigger atransmission of information from the instrumented medication package102, such as a list of medication cell accesses since a lasttransmission, or over a given period of time.

The incorporation of a unique identity associated with the triggersignal may also be used as part of an encryption algorithm, such thatdata transmitted from an instrumented medication package 102 may utilizethe random portion of the package identifier as a seed for an encryptionroutine. Thus, the random number would need to be known in order totrigger a transmission, as well as to understand the meaning of theresultant transmission.

In one form, the medication monitor 102 may be implemented by theprovision of specific functionality to a personal digital assistant(PDA). PDA's typically include the ability to accept add on modules,with control of the module being provided by the control circuitry ofthe PDA. In such an embodiment, the general functionality of the PDA maybe utilized to provide the display and interface capabilities. Displayfunctions could be accomplished through any display capable ofgenerating a signal which can be sensed by a patient, such as a visualdisplay, an auditory display (buzzer or other tone), or a vibratorydisplay. Taste and smell displays are also feasible, although presenttechnology limits the cost efficiency with which such displays can begenerated.

The PDA may be provided with a transmitter/receiver modem capable ofgenerating a trigger signal and receiving a responding transmission froman instrumented medication package. Although a radio frequency (RF)signal is discussed in the present implementation, light transmission,such as an infrared signal commonly used with items such as televisionremotes and calculators, may also be used, however such a signal may belimited in effectiveness due to its line of sight nature. An RFcommunications path using a frequency in common with pagers or cellphones could be susceptible to interference from cell phones and pagersbeing operated near the medication monitor 104 and instrumentedmedication package 102, especially if low transmission strengths areutilized to conserve power, or limit the ranges at which the signalscould be received.

Accordingly, use of a frequency range dedicated to medication monitorsmay improve the performance of the monitors by avoiding interferencefrom other transmitters. Multiple sets of medication monitors 104 andinstrumented medication packages 102 operating in the same area may beproblematic, in that transmissions associated with the individualmedication monitors 104 and instrumented medication packages 102 couldinterfere with each other. In the absence of some other method ofdeconflicting signals, limiting the transmission power of the individualmedication monitors 104 and instrumented medication packages 102 limitsthe range at which individual components would interfere with eachother. Although not a perfect solution, utilization of power limitedtransmissions allows a single frequency to be used for instrumentedmedication packages 102, such that the cost of the transmitters 106 onthe instrumented medication package 102, which may be disposable, may bekept at a minimum. Use of a common frequency furthermore increases thecommonality of the medication monitor 104, such that the cost impedimentto procuring a medication monitor 104 may be minimized.

Alternately, other methods of deconflicting the transmissions may beimplemented. Where instrumented medication packages 102 can have thecapability of transmitting at different frequencies, frequencies may beselected based on criteria likely to avoid generating conflictingtransmissions. For example, a frequency could be selected based on thedate of birth and first initial of a patient. The limitation to such analgorithm is the range of frequencies that an instrumented medicationpackage 102 must be capable of transmitting over. The frequency range isa function of the frequency difference between two signal frequenciesthat is required to avoid intolerable interference between transmissionsat the signal frequencies. Thus, the range may be determined by thenumber of signal frequencies to be implemented multiplied by thefrequency difference. A tendency exists that the broader the rangerequired of a transmitter 106, the higher the cost of the transmitter.Thus, minimizing the required range may allow reduced costs for thetransmitter 106 associated with an instrumented medication package 102.

Although the description to this point suggests the association of asingle patient with a medication monitor 104, a single medicationmonitor 104 may be utilized to monitor multiple patients concurrently.The ability to concurrently monitor multiple patients could beimplemented simply by association of a patient identification with aninstrumented medication package 102, 102 b, 102 c, when the instrumentedmedication package 102 was identified to the medication monitor 104. Forinstance, one person could monitor both his or her own medicationconcurrently with monitoring an instrumented medication package 102containing medicine prescribed for a significant other, parent, orchild. Alternately, multiple patient monitoring could be implemented toallow a nurse on a ward to ensure that medications for multiple patientswere accessed correctly. These implementations are discussed furtherbelow.

As generally illustrated in FIG. 2, the medication monitor 104 may befurther provided with a remote communications capability, such as acapability to communicate with a remote computer 200 via acommunications path 202. The communications path may be a wireless path,such as a satellite communications path 204 or a cellular transmissionnetwork 206 used with cell phones and/or other wireless handhelddevices. Alternately, the communications path may be a publicly switchedtelephone network 208 (hereafter referred to as a “PSTN”) path, or apre-wired communications path, such as a connection to the internet, orother form of network connection. Such access may be gained byconnecting the medication monitor 104 to a docking station 222.

The remote computer 200 may be a single computer or one of severalcomputers in a network. The remote computer 200 may be communicablyconnected to the medication monitor 104 when a communications path 200is established through one or more other computers, servers, or router.The remote computer 200 may contain a database 210 storing informationassociated with the medication taken by one or more patients. The remotecomputer 200 may also include a network access 212, such that thirdparties may access the stored data via a network. Additionally, theremote computer may be provided with e-mail or fax transmissioncapability, such that automated notices may be forwarded to recipientsas indicated.

The third party access to the network may include access to the systemby a physician through a physician's terminal 214, such that a physiciancould monitor the punctuality of a patient in accessing medication, orin determining what medication has been prescribed to a patient, such aswhat may occur when multiple physicians are responsible for the care ofa single patient. Information concerning medications prescribed to apatient could include medications prescribed, as well as medicationactually associated with a medication monitor 104, such that a physiciancould determine not only what medication was prescribed, but the statusof a patient in completing a course of medication. This informationcould allow a physician to tailor a prescription to work best in asituation where drug interactions could adversely affect the efficacy ofa particular medication.

A hospital terminal 216 could also be provided, to allow a hospital todetermine present medication in the event that a patient was brought toan emergency room. Again, access to information identifying medicationstaken, and when last taken, would allow the hospital to more effectivelytreat the patient.

A pharmaceutical manufacturer access 218 could be provided to allow thepharmaceutical manufacturer to accumulate ongoing efficacy informationregarding its products, such as information concerning the timelinesswith which patients actually take medication, as well as whether coursesof medication were completed, or not completed.

A health insurer access 220 could also be provided to allow an insurancecarrier to better track medications dispensed to a patient. The healthinsurer access, in conjunction with a pharmacy access 222, could beimplemented to allow prescriptions provided to the system through aphysician access to be dispensed via the pharmacy access 222, andaccounted for by the pharmacy access and health insurer accessesautomatically, reducing the administrative overhead associated with thedispensation process. Further, where two way communications between themedication monitor 104 and the remote computer 200 have beenimplemented, identification information associated with a particularinstrumented medication package 102 may be transferred directly from apharmacy access 222 to a medication monitor 104 via the remote computer200, removing the necessity of a patient entering data into themedication monitor 104 to associate a specific instrumented medicationpackage 102 with the monitor 104.

FIG. 3 illustrates a simple process embodying the present invention. Aninstrumented medication package 102 may be associated with themedication monitor 104. Association 302 informs the medication monitor104 of the need to start monitoring information from the instrumentedmedication package 102. The association 302 step may include theprovision of relevant information to the medication monitor 104, such asany identifiers for the instrumented medication package 102 needed totrigger a data transmission from the instrumented medication package.Additional information which may be associated is discussed furtherbelow.

Once the medication monitor 104 has been associated 302 with theinstrumented medication package 102, the medication monitor 104 maybegin monitoring the instrumented medication package 102 for transmittedinformation. The instrumented medication package 102 may be providedwith instructions to periodically transmit data, such as in accordancewith a predetermined schedule, or in response to the acquisition ofdata. Alternately, the instrumented medication package 102 may beprovided with instructions to transmit acquired data in response toreceipt of a valid trigger signal.

The use of a trigger signal as a means for instigating a datatransmission from an instrumented medication package 102 may haveseveral advantages. Where the instrumented medication package 102transmits only in response to a trigger signal, power may be saved inthe instrumented medication package 102 by the avoidance oftransmissions when a medication monitor 104 is out of range of theinstrumented medication package 102 transmitter 106. In order to verifyrange, the instrumented medication package 102 may be provided withdiscriminating circuitry to test the strength of a received signal.Signals below a threshold would be considered “out-of-range”, such thatthe instrumented medication package 102 would not transmit data inresponse to receipt of an otherwise valid trigger. A range test could beimportant, especially where a medication monitor 104 incorporated atransmitter 122 having greater capabilities than the transmitter 106 ofthe instrumented medication package 102, causing an ability for theinstrumented medication package 102 to receive signals transmitted bythe medication monitor 104, while at the same time the medicationmonitor 104 would be unable to receive signals transmitted from theinstrumented medication package 102. Such a signal strength test couldbe implemented as part of a trigger validation routine, such as where aunique identifier for the instrumented medication package 102 isimplemented as a trigger validation method.

The schedule at which the medication monitor 104 triggers a transmissionmay be based on various patterns. In a simple schedule, the medicationmonitor 104 could attempt to trigger a transmission at a fixedfrequency, such as once an hour. More complex schedules may be based onthe dosing schedule of the particular medication, on a schedule based onthe last successful triggering of a transmission, or based on a scheduleprovided by a patient.

For example, a patient could be prescribed a medication to be takenthree times a day, two doses at each time. The patient could decide totake the medication at 6:00 AM, 3:00 PM, and 10:00 PM, in order tosqueeze the three dosages into waking hours. The patient could providethe schedule to the medication monitor 104, which could then scheduleattempts to trigger a transmission ½ hour after each scheduled time.Should a trigger attempt fail, the medication monitor 104 could beprogrammed to either re-attempt to trigger a transmission at a certainamount of time after the failed trigger attempt, or could be programmedto generate an alarm requiring the patient to manually verify that ascheduled dosage had been taken. Alternately, if the medication monitor104 was able to successfully trigger a transmission, and thetransmission did not indicate that medication had been accessed, themedication monitor 104 could generate an alarm to warn a patient that ascheduled dosage had been missed.

Monitoring of an instrumented medication package 102, as illustrated,could be implemented by providing a schedule to a medication monitor104. The provided schedule could be based on information provided with abasic monitoring program used by the medication monitor. Alternately,the schedule could be provided via a remote computer 200, or entereddirectly into the medication monitor 104 when an instrumented medicationpackage 102 is associated with the medication monitor 104. Themedication monitor 104 would then test 304 the schedule to determinewhether it was the correct time to request a transmission from theinstrumented medication package 102. Such a determination would bedependant upon the test schedule provided. For example, if the scheduleinstructed that a transmission be generated every hour, the medicationmonitor 104 could check a time counter to determine whether an hour hadelapsed since the last trigger transmission. Alternately, where theschedule were based on generating a trigger transmission at a specifictime, the medication monitor could compare the scheduled time with thetime shown by an internal clock, and determine to generate a triggertransmission when the scheduled time and clock time were the same.

If it were determined 306 that the schedule indicated that a triggertransmission should be transmitted, the medication monitor couldtransmit 308 a trigger transmission. The instrumented medication package102 would receive 310 the trigger transmission, and respond bytransmitting 312 information to the medication monitor 104. Theinformation could be as simple as an acknowledgment of receipt of thetrigger signal, signifying an absence of relevant data to be reported,or a report merely informing the medication monitor which medicationcontainment cells had been accessed. The transmission could also informthe medication monitor of other information, such as times whencontainment cells were accessed, or other parameters monitored by theinstrumented medication package.

The transmitted information would be received 314 by the medicationmonitor, which could store the information, or disseminate theinformation to a remote computer 200, as indicated by the internaloperating instructions 112 of the medication monitor 104. The medicationmonitor 104 could then return to waiting for the next scheduled triggertransmission time.

Concurrently with monitoring an associated instrumented medicationpackage, the medication monitor 104 could monitor for data accessrequests forwarded by the remote computer. If a data access request werereceived 316, the medication monitor 104 could report 320 the requesteddata to the remote computer, and continue monitoring the instrumentedmedication package according to the schedule.

ALTERNATE EMBODIMENTS

The systems and method described above include functionality providingbenefits beyond the illustrated association between a patient and amedication monitor 104. As noted, a medication monitor may be taskedwith monitoring medication for more than one patient. A medicationmonitor 104 may also be associated with multiple patients, such as amedication monitor 104 being associated with a family having multiplemembers, such that one member could track medication usage of multiplemembers of the family, such as a mother tracking a teen-aged child'staking of an antibiotic for an ear infection, while simultaneouslytracking her husbands taking of a medication for heartburn.

Alternately, the medication monitor 104 could be associated with asingle medical care provider, such as a nurse, who is responsible formedication regimens for a group of patients. Implementation ofcommunications path 202 between the remote computer 200 and themedication monitor 104 would allow the remote computer 200 to monitormedications accessed by the nurse for dispensation to patients, suchthat the medications accessed by the nurse could be monitored in asufficiently rapid fashion to allow errors in accessing medication to becaught before the medication was delivered to patients. Such acommunications path could be a direct connection between the medicationmonitor 104 and the remote computer 200, such as a wireless networkconnection. Furthermore, medications to be dispensed could be trackedvia the remote computer 200, such that information identifying whichmedications to access for which patient could be downloaded from theremote computer 200 to the medication monitor 104. If single dosageblister packs were utilized for medication dispensation, a further checkcould be incorporated through the association of a patient with aspecific room having a specific fixed receiver in addition to thenurse's medication monitor 104, such that accessing medication in a roomfor which the associated patient is not indicated would result in thetriggering of an alarm through the medication monitor 104, indicatingthat the nurse should verify the medication being dispensed in the room.

Passive RFID Capabilities

In addition to relying on an active circuitry using an on-board powersupply, the present invention may use a hybrid system combining activeand passive circuitry to assist in the medication monitoring anddispensation. A passive system uses the energy of radio frequencytransmissions as a power source for responding to a remote transmitter.The large advantage of a passive system is that no on-board power supplyis required. The limitation is that the absence of an on-board powersupply may limit the operation of monitoring circuitry when the RFtransmission is not sufficiently strong to power the circuitry. Such alimit may also prevent the operation of a clock on the instrumentedmedication package 102.

Passive RF circuitry is used in anti-theft RFID systems, such that whenthe RFID tag is located within range of a RF transmitter transmitting onthe required frequency, the passive RFID tag responds by transmitting anidentification signal. Typically, the limitation of RF signal strengthas a power source for the passive RFID limits a response to occurringwhen the RFID tag is 3-5 feet from the RF transmitter. The circuitrywithin the RFID may be hardwired such that software is not required inorder for the RFID chip to function. The RFID chip thus may function asa circuit rather than a general purpose computer executing instructions.

Hybrid Passive and Active Circuitry

The limitation of active monitoring capabilities inherent in a passiveRFID only equipped instrumented medication package may be overcome byimplementation of hybrid passive and active circuitry on an instrumentedmedication package. FIG. 4 shows a hybrid instrumented medicationpackage 400 utilizing both passive RFID circuitry 402 for monitoring thepackage before the package is dispensed, as well as active circuitry 404for more specifically monitoring the accessing of medication afterdispensation. The active circuitry 404 may be provided with a switch(not shown) for connecting a power source to the circuitry, such asdescribed in applicant's U.S. patent application Ser. No. 10/234,021,titled “Power Control For Instrumented Medication Package” and filedherewith. The use of a switch to enable connecting the power source 406at the time of dispensation allows the use of a smaller power supply406, as the power supply 406 does not need to provide energy prior tothe package being dispensed.

The passive circuitry 402 and active 404 circuitry may be embodied inseparate passive RFID and active RFID chips, with the active RFID chipbeing provided with sufficient capabilities to monitor times at whichmedication was accessed, times at which medication was due to be taken,expiration dates, or environmental sensors to monitor patient storage ofthe instrumented medication package.

Such a hybrid active and passive system would allow monitoring of thepackage while the package was in storage, such as in a pharmacy area, aswell as monitoring of the package while the package was near amedication monitor. As discussed above, the medication monitor could becommunicably connected to a network to allow dissemination ofinformation received from the package to relevant parties, orcommunication of information from relevant parties to the package, suchas to allow the downloading of medication times, or an expiration date.As is evident from this instruction, information such as medicationtimes or expiration dates would not need to be downloaded to the packageat the time of production, simplifying the task of providing requisitestorage for the information on the instrumented medication package.

The circuitry necessary to provide severable conductors 118 for eachcontainment, for both the active circuitry and passive circuitry, couldbe accomplished by utilizing the same circuitry for both aspects of thecircuitry, or by providing redundant severable conductors 118. Redundantseverable conductors 118 could be accomplished though the printing ofmultiple conductive layers onto the package closure.

The ability of the RFID chip to be hardwired allows the chip to functionwithout first requiring the chip to determine its internal operatinginstructions. This capability may allow enhanced monitoring of thecontents of an instrumented medication package 102 to which passive RFIDcircuitry 402 is attached when the passive RFID circuitry 402 iscombined with an instrumented medication package 102. By integrating theseverable conductors of an instrumented medication package 102 into thecircuitry of the RFID chip, the circuitry of the severable conductorsmay be used to form a portion of the RFID circuitry, such that a portionof a response identifier generated by the passive RFID chip may bedetermined by the condition of the severable conductors. This may allowcontinuous monitoring of the severable conductors when the instrumentedmedication package 102 is within the transmission range of a requisiteRF transmitter, without requiring an internal power source. Although theintegration of the severable conductors 118 with passive RFID circuitry402 does not provide for monitoring of times at which severableconductors 118 are severed locally, it does allow an RF receiverassociated with the RF transmitter, (together embodied in a passivecircuitry transceiver 404) to monitor the responding identificationinformation, such that the severing of a severable conductor 118 willchange the identification code transmitted by the passive RFID circuitry402, allowing a central station (not shown) receiving information viathe Passive Circuitry Transceiver 404 to detect the severing of aseverable conductor 118 within an instrumented medication packageincorporating passive RFID circuitry 404.

As theft of medications is an important issue in hospital pharmacies,the incorporation of such a system into a hospital pharmacy may allowaccessing of medication within the range of a RF transmitter/receiverpair to be detected when medications are accessed within a pharmacy.Such a capability may be used to reduce the unauthorized access tocontrolled substances, such as pain killers, since the accessing ofmedication within a containment may be rapidly communicated to the RFtransmitter/receiver pair. Thus, control of the medication containedwithin an instrumented medication package may be monitored when theinstrumented medication package is within a hospital pharmacy, allowingimproper accessing of controlled substances to be detected and respondedto.

A system embodying such a concept in a pharmacy environment is show inFIG. 5. The hybrid instrumented medication package 400 may be equippedwith a passive RFID circuitry 404 connected to severable conductors 118,such that the severable conductors 118 form a portion of the passiveRFID circuitry 404. The passive RFID circuitry may be installed on aninstrumented medication package 502, such that the severable conductors118 are multiplexed to reduce the number of necessary leads. Powerreceived by the passive RFID circuitry may be applied to one end of eachseverable conductor 118, with the severable conductors 118 functioningas switches for generating an identification signal. For example,considering the identification to be a digitally encoded identification,where the passive RFID circuitry 404 receives power from a severableconductor lead (indicating continuity of the lead), the passive RFIDcircuitry 404 may transmit a 1, while where no power is received at thelead, the passive RFID circuitry 404 may transmit a 0. The passive RFIDcircuitry 404 may have a number assigned, such as for example a productcode for tracking purposes. The passive RFID circuitry 404 would thustransmit the product code, with the connector status code appended tothe product code. As an example, if a hybrid instrumented medicationpackage 400 was assigned a product code of decimal 2897 (binary101101010001), and had 12 containments, each with a severable conductor,if containments 6 and 7 were open, the passive RFID circuitry 404 wouldtransmit 101101010001000001100000 in response to a signal received froma monitoring station 504 comprised of an RF transmitter, an RF receiver,and a network connection.

In addition to the product code and status code, a unique identifier forthe specific hybrid instrumented medication package 400 may also beimplemented. For example, the passive RFID circuitry 404 may contain aseries of internal circuits that may be originally continuous, but whichmay be broken through the application of a voltage exceeding thecapability of the circuit. As such, the circuits may be selectivelybroken prior to the passive RFID circuitry 404 being connected to aninstrumented medication package 102, in order to set a package specificcode. Alternately, Programmable Read Only Memory (PROM) may beincorporated to allow programming of an identification into the RFIDcircuitry. Either method allows mass-produced chips to be customizedbased on an identity value. For example, using the above binary coding,the package could be assigned a package specific code of 101000010000(or 1288 in base 10 numbering), such that the RFID would respond with101101010001 101000010000 000001100000. The signal need not be in binaryform, but may rather use any of a number of other forms, such asfrequency modulation to reduce the duration of a transmission needed totransmit an identifier.

Additional identification may be implemented as desired. For example,rather than incorporating a specific package identifier, the identifiermay relate to a production batch, allowing identification of aproduction site, production date, or lot shipping information. Alternateor additional information may include the National Drug Code, expirationdate, and/or a manufacturer tracking identifier.

Deconflicting signals from a concentration of hybrid instrumentedmedication packages, such as could occur where a number of instrumentedmedication packages were stored in a pharmacy area, may be accomplishedthrough several methods.

Instituting a delay, such that an passive RFID circuitry would respondonly periodically, would reduce signal overlap, such that the timingcharacteristics of a signal could be used to distinguish the signal ofone passive RFID circuitry from other transmitting passive RFIDcircuitries. Alternately, transmission frequencies could be varied toallow differentiation between transmitting passive RFID circuitries.

A pharmacy area, or any other area where such monitoring is desired,such as in a drug store or nursing station, may be provided with an RFtransmitter/receiver pair which is connected to a network connection.The network connection may be communicably connected to a centralcomputer which stores information concerning medications. The centralcomputer 512 may additionally be communicably connected, such as througha network 514, to a dispensing input/output station 516 (hereafter “DI/Ostation”), to allow a pharmacist to communicate dispensation of a hybridinstrumented medication package 400 to the central computer 5112.Although the DI/O station 516 is illustrated as a typical desktopcomputer, the DI/O station 516 may be implemented in any device whichcan be communicably connected to the central computer 512 to allow apharmacist or other entity dispensing medication from the pharmacy areato communicate with the central computer 512. For example, a personaldigital assistant, provided with the relevant operational capability,could be used. Such an embodiment could additionally include an RFtransmitter/receiver pair to allow a specific instrumented medicationpackage identifier to be transmitted directly from a package to the DI/Ostation 516. The central computer 512 may additionally be provided witha means for indicating unauthorized accessing of a medication to aresponsible third party, such as a security input/output (hereafter“SI/O device” 518). The SI/O device 518 could simply be a printer whichprints out administrative reports regarding the status of instrumentedmedication packages, or could be a computer assigned to a groupresponsible for monitoring the unauthorized accessing of medications,such as a security group.

Use of such an instrumented medication package in the pharmaceuticalsystem described is shown in the process illustrated in FIG. 6. Once aninstrumented medication package was placed into the pharmaceutical area,the RF transmitter would transmit sufficient energy to generate aresponse by the RFID chip. The transmitted response would be received bythe RF receiver, and communicated to the network connection. The networkconnection would then forward the transmitted information to the centralcomputer. The central computer could then verify the status of theinstrumented medication package by parsing the identificationinformation received. The product code and package code portions of theidentifier could be used to update an inventory list for the pharmacyarea at which the identifier was received. The received status codecould be tested to determine whether the status of the individualconnectors had changed in transit, such as if medication was improperlyaccessed in transit. If a status change were detected, the centralcomputer could notify the appropriate authorities, such as via a SI/Odevice as described above. The status of the package would continue tobe monitored while the instrumented medication package was stored in thepharmacy area. As such, should medication contained in the package beaccessed improperly, the access would be detected, such that theimproper accessing could be attributed to the person improperlyaccessing the package.

Tracking of the instrumented medication package could be discontinuedonce the instrumented medication package was transferred from thepharmacy area, or if the instrumented medication package was dispensed.Information regarding such transfer or dispensation could be provided tothe central computer via the DUO station, such that the central computercould account for dispensation into a patient's bill, or monitortransfer to ensure that a package reached a transfer destination. Shouldmedication be accessed during transit, the accessing would be detectedonce the medication package reached its destination, such that the taskof identifying who accessed the medication would be limited to thoseresponsible for the transfer.

Combined Process

The present invention may be embodied in a process integrating aninstrumented medication package within a health care system, as shown inFIG. 6. In order to provide for security tracking of a hybrid passiveand active IMP (hereafter referred to as a “HIMP”) stored within apharmacy area, a passive monitor or monitors may be located 602 in thepharmacy area. The locating 602 of the passive monitor may allow passivecircuitry indicating the presence of HIMP to be activated by the passivemonitor, through the passive monitor transmitting 606 and trigger signalwhich causes a response 608 from the HIMP indicating the identity andcontainment status of the HIMP. The passive monitor is preferablycommunicably connected with a central computer, such that the centralcomputer can coordinate information associated with the HIMP, as well aswith involved physicians, patients, pharmacists, and/or otherindividuals or entities involved in the healthcare process.

A HIMP will typically be delivered 604 to a pharmacy area as part of arestocking evolution. The HIMP may be transported from a prior holdingarea, such as a pharmaceuticals storage area, or from thepharmaceuticals manufacturer. Data and information concerning the HIMPmay typically be maintained by the entity storing the HIMP prior todelivery to the pharmacy, such that a record as to the status ofcontainments within the HIMP may be made available to or transferred tothe central computer. This data may form a baseline for statusmonitoring by the central computer.

As part of normal monitoring, the passive monitor may transmit 606 atrigger signal to which the HIMP is responsive, generating a response608 from the passive circuitry contained on or in the HIMP. If thetrigger signal is particular to a HIMP, the central computer may forwardan instruction to the passive monitor to generate the trigger signal todetect the particular HIMP. For example, where a pharmaceuticalmanufacturer was shipping a quantity of medication contained in HIMPs tothe pharmacy area, the pharmaceutical manufacturer could inform thecentral computer in advance of the pending shipment, as well as thespecific trigger signal information associated with the HIMPs, as wellas information concerning status of the containments within the HIMPs.Such information could be contained as part of routine invoicingdocuments generated in response to an order for medication.

In response to the trigger signal, the HIMP could transmit 606 with anidentifier and containment status. Containment status may be ofparticular import where the medication contained in the HIMP is acontrolled substance, such as a pain killer. This response would bereceived 610 by the passive monitor, informing the passive monitor ofthe presence and status of the HIMP.

If the passive monitor does not detect 610 a response from the HIMP, thecentral computer may be informed 612 of the lack of a response. A lackof a response may indicate that the HIMP has been removed from thepharmacy area, or is out of range of the passive monitor. Either way,the pharmacy may likely have an interest in investigating the lack of aresponse to ensure that the HIMP, and the medication contained therein,is not missing. Alternately, where the passive monitor is merelyresponsible for forwarding received responses, the determination that aresponse that should have been received was not may be made by thecentral computer. In such a case, the central computer would track theinventory of the pharmacy. When a HIMP is recorded as having beendelivered to the pharmacy area, the central computer would monitor forresponses forwarded from the passive monitor. If no responses werereceived, the central computer could institute actions as desired, suchas notice to a pharmacist to verify the presence of the HIMP in thepharmacy area, or instructions to security to determine the location andstatus of the HIMP.

If the passive monitor detects 610 a response, the passive monitor mayforward 614 the received response to the central computer. The form ofthe response may be determined by the manner chosen of distributingmonitoring responsibilities. If all processing is to be accomplished bythe central computer, the passive monitor may merely relay the responsefrom the HIMP to the central computer. If the passive monitor isassigned processing tasks, such as testing the reported status ofcontainments against a prior status to detect changes, the passivemonitor may only report a “no change” report for a particular HIMP. Suchdistribution of tasking may be dependent upon the architecture chosen toimplement the central computer, passive monitor, and the communicationsconnection between them. Accordingly, the form of the response may evenbe a non-transmission, in the case of a protocol reporting only changesin status. The response of the central computer 616 is discussed furtherbelow.

The passive monitor may continue to monitor the HIMP until it isdetermined 618 that the package has been dispensed from the pharmacy.Once it has been determined that the package has been dispensed, thecentral computer may be informed 620 that the package has beendispensed. Such information may be determined through a pharmacist orother dispensing entity entering information into a computer or networkdevice. Alternately, a separate monitor may be implemented at a portalthrough which medication is dispensed, such that the portal monitor maydetect a response from passive circuitry passing within range of theportal monitor.

As is evident from the potential use of such a portal monitor,additional monitors can be used at access points for the medicationstorage areas, allowing a delivery monitor to detect HIMP's beingdelivered, as well as HIMP's being dispensed. The use of the severableconductors 118 as a portion of the circuitry responsible for generatingan identification response may allow additional security, in thatremoval of the circuitry forming the monitoring and response circuitry,such as when such circuitry is implemented through a chip attachable toa medication package having the requisite severable conductors, wouldprevent the HIMP from responding correctly to a monitor in the storagearea.

The process associated with the central computer monitoring a HIMPstored in a storage area is shown in FIG. 6B. When the central computeris informed 604 of the delivery of a HIMP, such as when the HIMP isdelivered, the central computer may access 622 records, such as thosepreviously stored, or such as provided by a pharmaceutical manufactureror an entity responsible for transferring the medication, to receive arecord regarding the condition of the HIMP. Initially, the centralcomputer may presume the HIMP to be complete, such that the status ofthe severable conductors is initially assumed to be connected. Forexample, where 8 containments are included in the HIMP, and a 1 in therelevant position of the identification response indicates that aseverable conductor has not been broken, the central computer can use1111 1111 as the presumed identifier response, and base the generationof a notice upon the detection of a deviation from this code.

The central computer may compare 624 the status of the containments bycomparing the status portion of the identifier code, such as bysubtracting the previously stored code from the received code, andgenerating an alarm for any non-zero result. If a change in status isdetected 626, the central computer may evaluate and generate 628 anotice to have the change in status evaluated by an entity responsiblefor the security of the HIMP. For example, a hospital administrator maybe in formed, allowing the hospital administrator to manually verify thecondition of the HIMP. The simple notice function alone may assist inreducing unauthorized accessing of medication, since persons responsiblefor the unauthorized access would be aware of the ability of thehospital administration to detect the unauthorized access in such atimely fashion as to associate the unauthorized access with individualsin the area where the unauthorized access takes place through the timelydetection of the unauthorized access. Upon completion of the evaluationof a received status identifier, the central computer may also update630 a database storing information on the HIMP, such as to record thestatus at the recorded time to allow tracking of when an access orunauthorized access occurred.

As shown in FIG. 6C, the administrative aspects of a physicianprescribing medication may be integrated with the dispensing of aninstrumented medication package to reduce the administrative taskingassociated with prescribing the medication. This involvement may beginby the physician informing 632 the central computer of the prescription,potentially including dosing and scheduling information as may betypical of prescriptions. The central computer may then forward 634 theprescription information to a pharmacist, who can pull 636 theprescribed medication from the pharmacy storage area. The pharmacist maythen associate 638 the specific instrumented medication package with theprescription prior to dispensing 640 the medication, such as byinforming the central computer of the specific package number of theinstrumented medication package being dispensed. The pharmacist may alsoenable active circuitry, such as by charging or recharging a powersupply associated with the instrumented medication package, or byswitching the package on if a switching capability is provided. Such atransition may also include disabling of the passive circuitry toprevent the passive circuitry from being read now that the package isassociated with a particular package, and thus to some extent providesprivate patient information. As noted above, the pharmacist may inform642 the central computer of the dispensation, such that a centraldatabase tracking medication information and patient records can beupdated. Upon receipt of such notification, the central computer mayalso update 644 the inventory of the pharmacy, assisting in thereplenishment of pharmacy stocks.

FIG. 6D shows a process according to the present invention involving aninstrumented medication package associated with a patient to whom thepackage has been dispensed, illustrating the interaction between thepatient and the data available from use of the instrumented medicationpackage. Initially, the patient receives 646 the instrumented medicationpackage. The patient may need to associate the instrumented medicationpackage with a medication monitor, or the central computer may informthe medication monitor of the association with the instrumentedmedication package. The medication monitor may then access 648background information associated with the particular instrumentedmedication package and medication contained therein. The backgroundinformation may be instructions and warnings regarding the medication,notices regarding how the medication should be taken, or what activitiesshould be curtailed while the medication is being taken. Suchinformation may be displayed to the patient by the medication monitor,such as when a display or speaker is provided on the medication monitor.A monitoring schedule may be provided 650 to the medication monitor. Themonitoring schedule may be dependant upon factors associated with theparticular medication, such as the degree of adverse impact due to latetaking of the medication by a patient, or the frequency with which themedication should be taken. The monitoring schedule may also be relatedto an intake schedule, such that the medication monitor would query theassociated instrumented medication package to determine whethermedication had been taken on time, based on the time when the medicationwas to be taken. The monitoring schedule does not need to be fixed orperiodic, but may be varied as required. For example, where no access tomedication is detected at a scheduled intake time, the periods betweenrepeat queries may decrease the longer the time past the scheduledintake time.

An intake schedule 652 may be provided to the medication monitor toassist in providing information to a patient taking a medication, suchas through providing alarms when a scheduled dosage has been missed, orthrough being able to acquire and display for a patient informationregarding adverse consequences of not following an intake schedule. Suchan adverse consequence display could, for illustration purposes, informthe patient that the effectiveness of a course of medication is reducedby 25% when the intake schedule is not met, or that the likelihood ofthe medical condition developing a resistance to the medicationincreases by 25% when the intake schedule is not met.

The intake schedule may then be monitored 654 to assist a patient infollowing the intake schedule. It may not be desired to tie themonitoring schedule to the intake schedule such that information requesttransmissions are made in accordance with the intake schedule. If amedication is amenable to misuse, such as by taking the medication toofast, a patient taking medication before a scheduled intake time wouldnot be detected in a timely fashion by queries generated only at intaketimes. Accordingly, the intake schedule may be a factor in themonitoring schedule, but may not be controlled by the intake schedule.

If an intake time arrives without a patient accessing a requisitecontainment 656, the medication monitor may generate 658 a signal to thepatient that medication is due to be taken. The signal can be anaudible, tactile, or visual display indicating to the patient that ascheduled intake event has been missed. For example, a buzzer orvibrator associated with the medication monitor may be actuated, withthe signal not ceasing until manual intervention by the patient. As amedication monitor may not be continuously in contact with a patient, abuzzer or bell provides a greater physical range over which a signal canbe received by a patient, while the use of a buzzer allows a quiet mode,such as if a patient is in a business setting where a buzzer or bellwould be offensive.

The medication monitor could continue to monitor 660 the instrumentedmedication package in accordance with the monitoring schedule If datawere received from the instrumented medication package, the data couldbe forwarded 664 to the central computer. The central computer couldmake this information available to a physician responsible or themedical care of the patient, to a pharmaceutical manufacturer orregulatory authority collecting data on the patient's compliance withthe intake schedule, or to other entities involved in the healthcareprocess.

Instructions could also be transmitted 662 from the central computer tothe medication monitor. Such instructions could alter the intakeschedule, the monitoring schedule, or provide information for a patientassociated with the medication monitor. For example, a patient couldtelephone a physician regarding complications associated with the takingof a medication. The physician could adjust the intake schedule for themedication, by informing the central computer of the changed intakeschedule. The changed intake schedule could be transmitted from thecentral computer to the medication monitor, which could then prompt apatient associated with the medication monitor in accordance with thechanged intake schedule. Alternately, a physician could have informationregarding a complication forwarded to the medication monitor for displayto the patient. If the instructions received were patient instructions668, the patient could be signaled 670, such as through an audible,tactile, or visual signal, and the instructions displayed for thepatient on the medication monitor. The provision of the instructionsthrough the medication monitor could also be used to documenttransmission to and receipt of the instructions by the patient, such asby having the instructions remaining displayed on the medication monitoruntil a patient indicates understanding of the instructions.

Finally, if the medication monitor had been provided with informationregarding the total number of medication containments included in aninstrumented medication package, the medication monitor could monitorthe number of medication containments remaining unaccessed to determinewhether the HIMP was finished 672, and inform 674 the central computerwhen the medication package had been completed, or inform the centralcomputer in advance of completion of the medication in the medicationpackage to allow a refill to be prepared.

As is evident from the above description, the present invention may beembodied in other specific forms than the embodiments described abovewithout departing from the spirit or essential attributes of theinvention. Accordingly, reference should be made to the appended claims,rather than the foregoing specification, as indicating the scope of theinvention.

1. A method for monitoring or tracking a package having a packageintegrity and an associated at least one condition, the methodcomprising: detecting the integrity of the package using an integritysensor being integrated into the package; detecting the at least onecondition; and transmitting data indicative of the detected packageintegrity and detected at least one condition.
 2. The method of claim 1,wherein the transmitting is to at least one of a plurality of transitoryreceivers, and further comprising re-transmitting at least a portion ofthe transmitted data to a central monitor.
 3. The method of claim 1,wherein: the condition detecting uses a condition sensor beingintegrated into the package; the at least one condition comprises atleast one environmental condition; and, the transmitting data indicativeof the detected package integrity and detected at least one condition isfrom the package.
 4. The method of claim 1, wherein the package containsa plurality of items each having at least one of integrated itemintegrity sensors and integrated item condition sensors, furthercomprising transmitting data indicative of detected item integrities anda detected at least one condition from the package upon package access.5. The method of claim 1, wherein the at least one condition comprises alocation, and the method further comprises storing at least a portion ofthe transmitted data so as to be indicative of a sequence in which itwas transmitted.
 6. The method of claim 1, further comprisingselectively initiating at least one action responsively to thetransmitting or lack thereof.
 7. The method of claim 1, wherein thepackage comprises at least one sealed item, and the integrity sensorcomprises at least one severable connector associated with the at leastone sealed item.
 8. The method of claim 7, wherein the at least oneintegrity sensor determines whether the at least one severable connectorhas been severed, and the method further comprises selectivelyinitiating at least one action responsively to the determining.
 9. Themethod of claim 8, wherein the at least one condition comprises alocation, and the selectively initiating is dependent on the determinedlocation.
 10. The method of claim 9, wherein the selectively initiatedaction comprises transmitting at least one alert.
 11. The method ofclaim 1, wherein the at least one condition comprises at least one of atemperature condition, a humidity condition, a light exposure condition,a location condition, a date condition and an access condition.
 12. Themethod of claim 1, further comprising comparing at least a portion ofthe transmitted data to stored data.
 13. The method of claim 2, furthercomprising comparing at least a portion of the re-transmitted data tostored data, and transmitting data to at least one of the transitoryreceivers dependently upon the comparing.
 14. The method of claim 1,further comprising: comparing at least a portion of the transmitted datato stored data; transmitting data responsively to the comparing; andupdating the package dependently upon the data transmitted responsivelyto the comparing.
 15. The method of claim 12, wherein the comparingverifies at least one of patient identification, prescription dosage,dosage form, intake schedule and drug identification.
 16. The method ofclaim 15, further comprising indicating approval of at least one actionresponsively to the comparing.
 17. The method of claim 16, wherein thepackage comprises at least one sealed item, and the integrity sensorcomprises at least one severable connector, and the method furthercomprises: detecting severance of the severable connector subsequent tothe indicating approval; and transmitting data indicative of thedetected severance from the package.
 18. The method of claim 8, whereinthe at least one action is to order at least one other package.
 19. Themethod of claim 1, wherein the detected condition is indicative of anoccurrence of at least one predetermined event.
 20. The method of claim19, wherein the occurrence of the at least one predetermined event isthe at least one condition exceeding a predetermined threshold.
 21. Themethod of claim 1, further comprising: providing a plurality ofmonitors; providing a plurality of devices; associating at least one ofthe devices with at least one patient; transmitting data from at leastone of the associated devices to at least one of the monitors; wherein,the data indicative of the determined integrity is transmitted from thepackage to at least one of the monitors; whereby, medical care facilityactivities and the patient are coordinated.
 22. The method of claim 2,further comprising presenting a representation of at least a portion ofthe transmitted data using at least one of the transitory receivers andcentral monitor.
 23. The method of claim 1, wherein the at least onecondition comprises location, data indicative of which is transmittedvia at least one satellite.
 24. The method of claim 21, furthercomprising: associating the package with at least one of the monitors;comparing at least a portion of the transmitted data to stored data,wherein the comparing verifies at least one of patient identification,prescription dosage, dosage form, intake schedule and drugidentification; indicating approval of at least one action responsivelyto the comparing.
 25. The method of claim 24, further comprising:detecting a change in package integrity subsequent to the indicatingapproval; and transmitting data indicative of the detected change.
 26. Amethod for monitoring or tracking a package having a package integrity,the method comprising: detecting a change in the integrity of thepackage using an integrity sensor being integrated into the package;selectively transmitting data responsively to the detected packageintegrity change from the package.
 27. A system for monitoring ortracking a package having a package integrity and being subject to atleast one condition, the method comprising: an integrity sensor beingintegrated into the package; at least one condition sensor beingintegrated into the package; and a radio frequency transmitterintegrated into the package, responsive to the integrity and conditionsensors, and transmitting data indicative of a detected packageintegrity and detected at least one condition from the package.
 28. Asystem for detecting unauthorized access to a plurality of packages eachhaving a package integrity, the system comprising: a plurality ofintegrity sensors integrated into corresponding ones of the packages;and a plurality of transmitters integrated into corresponding ones ofthe packages; wherein, each of the radio frequency transmittersselectively transmits data responsively to sensed changes in packageintegrity by one of the integrity sensors being integrated into a samecorresponding one of the packages.